FDA Adverse Event
Malfunction
Summary report: N
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
MDR report key: 2954288
·
Received January 9, 2013
Report
- Report Number
- 3003793491-2013-00043
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 12, 2012
- Manufacturer
- ZOLL CIRCULATION INC
- Product Code
- DRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS RECEIVED THE DEVICE ASSOCIATED WITH THIS REPORT; HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. NO ADVERSE EVENT REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PLATFORM INDICATED USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) THAT COULD NOT BE CLEARED. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11139 | AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | CARDIAC CHEST COMPRESSOR | DRM | ZOLL CIRCULATION INC | 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |